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U.S. Department of Health and Human Services

Class 2 Device Recall Prismaflex M

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  Class 2 Device Recall Prismaflex M see related information
Date Initiated by Firm July 22, 2021
Create Date August 27, 2021
Recall Status1 Terminated 3 on January 17, 2024
Recall Number Z-2378-2021
Recall Event ID 88351
510(K)Number K041005  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Baxter PrismaFlex, REF numbers:
a) 106696 (M 60 SET)
b) 106697 (M 100 SET)
Expansion:
c) 107144 (TPE2000 SET)
d) 115307 (M 150 SET)
e) 115309 (ST 100 SET)
f) 955467 (M 150 SET)
g) 955468 (ST 100 SET)
h) 955595 (M 100 SET)
i) 955596 (ST 150 SET)

Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Code Information a) 106696, Lot Numbers: 20B2329M b) 106697, Lot Numbers: 20B2323M, 20B2328M (expanded to include 20B2326M) Expansion: c) 107144, Lot Number 20B2325M d) 115307, Lot Number 20B2321M e) 115309, Lot Number 20B2310M and 20F0201 f) 955467, Lot Numbers 20A2604M, 20A2606M, 20A2607M, 20A2608M, 20B2331M, 20B2332M, 20B2333M, 20B2334M, 20B2335M, 20B2336M, 20B2347M, 20A2605M g) 955468, Lot Numbers 20A2602M, 20A2603M, 20B2308M, 20B2311M, 20B2312M, and 20B2324M h) 955595, Lot Numbers 20A2609M, 20A2610M, 20B2337M, 20B2338M, 20B2339M, 20B2340M, 20B2341M, 20B2342M, 20B2343M, 20B2344M, 20B2345M, and 20B2346M i) 955596, Lot Numbers 20A2601M, 20B2302M, and 20B2309M
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming
FDA Determined
Cause 2		 Vendor change control
Action The firm notified its consignees of the recall by letter on 07/22/2021. The letter explained the issue and requested the return of the affected product. Distributors were directed to notified their consignees.
Quantity in Commerce 64275 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = GAMBRO RENAL PRODUCTS
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